MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAVION DLVR; WIRE, GUIDE, CATHETER

Model Number	1115
Medical Device Problem Codes	Entrapment of Device (1212); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire became stuck in the lesion, and once removed, the tip broke off inside of the balloon.A savion dlvr guidewire was selected for a percutaneous transluminal angioplasty procedure in the patient's right anterior tibial artery.The lesion was a sub total occluded artery, and heavily calcified.The physician was trying to cross the lesion with the savion wire, but the wire became stuck in plaque or a piece of calcium.While trying to pull the wire out, the tip became unraveled.The physician was able to get it loose and capture the wire, but the tip broke off inside of an unspecified balloon.Everything was removed together as a unit.Nothing was left behind in the patient.A different wire was used to cross the lesion and then a coyote was used to complete the procedure.The patient tolerated everything well.No patient complications were reported.The patient condition after the procedure was fine.
Event or Problem Description
It was reported that the wire became stuck in the lesion, and once removed, the tip broke off inside of the balloon.A savion dlvr guidewire was selected for a percutaneous transluminal angioplasty procedure in the patient's right anterior tibial artery.The lesion was a sub total occluded artery, and heavily calcified.The physician was trying to cross the lesion with the savion wire, but the wire became stuck in plaque or a piece of calcium.While trying to pull the wire out, the tip became unraveled.The physician was able to get it loose and capture the wire, but the tip broke off inside of an unspecified balloon.Everything was removed together as a unit.Nothing was left behind in the patient.A different wire was used to cross the lesion and then a coyote was used to complete the procedure.The patient tolerated everything well.No patient complications were reported.The patient condition after the procedure was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned and tip damage was noted as part of an overall visual revision.The device was kinked at the middle section.Additionally, the spring tip was stretched.The overall length was within specification.The outer diameter of the distal tip was not able to be measured because it was stretched.The outer diameter of the middle section and proximal section were within specification.

• Brand Name: SAVION DLVR
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8540755
• Report Number: 2134265-2019-04200
• Device Sequence Number: 10840801
• Product Code: DQX
• UDI-Device Identifier: 08714729978862
• UDI-Public: 08714729978862
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 1115
• Device Catalogue Number: 1115
• Device Lot Number: 0022457824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1